Kornimate/medical-research-clean huggingface dataset:
stromal vascular fraction (svf) for treatment of enterocutaneous fistula (hulputc)

Conditions: Enterocutaneous Fistula

Summary: the purpose of this study is to determine safety of stromal vascular fraction (svf) for the treatment of enterocutaneous fistula.

sf-12 test

Eligibility criteria:
inclusion criteria: * signed informed consent * enterocutaneous fistula * men and women over 18 years old. good general state of health according to the findings of the clinical history and the physical examination exclusion criteria: * presence of severe proctitis or dominant active luminal disease requiring immediately therapy * patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start * patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion * patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years * patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study. * patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study * patients with congenital or acquired immunodeficiencies. hiv, hbv, hcv or treponema infection, whether active or latent * patients who have suffering major surgery or severe trauma in the prior 6 months * pregnant or breastfeeding women * patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.

Keywords: enterocutaneous fistula adipose derived stem cells
management of mineral and bone disease in hemodialysis-calcitriol vs. paricalcitol

Conditions: Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia

Summary: the purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised kidney disease: improving global outcomes (kdigo) parathyroid hormone targets.

active vitamin d analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (mbd) for the past decade. intravenous calcitriol is an active vitamin d analog which is nearly identical to natural 1, 25 vitamin d3. calcitriol results from the hydroxylation of previtamin d3 in the liver and kidney. paricalcitol, 19-nor-1 , 25-dihydroxyvitamin d2, is a newer agent vitamin d analog. this agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. although both formulations appear equally effective in suppressing parathyroid hormone (pth), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). due to this, paricalcitol is the predominant active vitamin d analog used in hemodialysis patients in the united states. two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin d analogs used in the near future: the liberalization of pth goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by medicare. these changes challenge previous studies that have analyzed the safety and efficacy of these medications. the purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of mbd in hemodialysis patients using the revised kdigo parathyroid hormone targets. our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of mbd in hemodialysis patients.

Eligibility criteria:
inclusion criteria: - all subjects will have been treated for at least three months on hemodialysis with iv paricalcitol. these subjects must have a most recent calcium level within the normal range, most recent phosphorus level \< 8 mg/dl and a most recent pth between 130-585 pg/ml exclusion criteria: patients will be excluded if: 1. age greater than 18 2. active malignancy 3. expected survival greater than 6 months 4. high likelihood of renal transplant during the study period. 5. low calcium bath 6. prior parathyroidectomy 7. use of calcimimetics
prevention of surgical wound infection

Conditions: Cardiac Surgery

Summary: to compare cost effectiveness of a polyurethane dressing or a vacuum therapy dressing versus the conventional gauze in the prevention of superficial wound infection y major cardiac surgery

it is a clinical prospective and randomized study. patientes will be randomized to three groups on the day of surgery: conventional gauze, polyurethane or vacuum therapy dressing. clinical al microbiological data will be monitorized to evaluate the infection rate of surgical wound , mediastinitis, days of hospital stay and consumption of antimicrobials.

Eligibility criteria:
inclusion criteria: * patient scheduled to cardiac surgery. * signed informed consent form exclusion criteria: * hypersensibility to dressings
autologous stem cell transplantation and maintenance therapy for multiple myeloma

Conditions: Multiple Myeloma

Summary: this trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in multiple myeloma patients treated with dose intensive chemotherapy (melphalan 200 mg/m2) with autologous pbsc transplant.


Eligibility criteria:
inclusion criteria: * must be 18 to 75 years of age. * ecog performance status of 0, 1 or 2. * patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. patients with basal cell and squamous cell skin cancers are eligible. * patients who are pregnant are ineligible. * patients must furnish written informed consent and hipaa authorization for release of personal health information. * patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. * patients must be hiv and htlv-i,-ii antibody sero-negative. * patients must have adequate visceral organ function exclusion criteria: * patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (bcnu) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction. * patients are ineligible if they are receiving any other investigational agents.

Keywords: multiple myeloma
the role of multimodality imaging in left atrial appendage closure

Conditions: Atrial Fibrillation

Summary: the aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. according to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of laac (total radiation dose, procedure time, fluoroscopy time, contrast amount). the investigators assume, that the success rate and safety of laac procedures is not reduced using unimodal preoperative imaging. regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. we assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (pdl, device thrombi).

left atrial appendage closure (laac) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. as the majority of candidates are elderly patients with multiple morbidities, the reduction of procedural burden is of huge significance. the aim of the present prospective, randomized, single-centre study is to examine the non-inferiority of unimodal (mdct) vs. multimodal (mdct+toe) preprocedural imaging in percutaneous left atrial appendage closure. the investigators are going to assess the success rate, safety and complications of laac procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural unimodal and multimodal appendage characterization and device sizing. multimodal procedural guidance (2d/3d toe, fluoroscopy-angiography) and multimodal postprocedural imaging (2d/3d toe, mdct) is going to be used to identify complications (peri-device leak, thrombus). the investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques. .

Eligibility criteria:
inclusion criteria: * patients, who have clinical indication to laac and are undergoing percutaneous laac procedure in gottsegen national cardiovascular center from 10.03.2021 to 31.12.2025 * age above 18 years * informed consent * legal capacity exclusion criteria: * age under 18 years * pregnancy * incapacitation * absence of consent * esophageal stenosis or diverticulum * active esophageal bleeding * ct-contrast agent allergy * severe chronic kidney disease (gfr\<15 ml/min/1,73 m2) * appendage thrombus (mobile/with significant embolic risk) * life expectancy shorter than 12 months * active infection * significant mitral valve stenosis * mechanical heart valve * open heart surgery is indicated

Keywords: atrial fibrillation ischemic stroke left atrial appendage closure bleeding
safety study of recombinant m2e influenza-a vaccine in healthy adults

Conditions: Influenza

Summary: this multi-center study will be conducted in the united states with up to 80 healthy adult subjects. subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. subjects will be randomized according to a randomization scheme.

all subjects will be followed up for 60 days post-randomization and through the influenza season. following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. the subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Eligibility criteria:
inclusion criteria: * adult males or females 18 - 40 years of age in good general health exclusion criteria: * known allergies or severe reactions to any of the vaccine components including those to adjuvants * history of severe allergic reactions, including angioedema; * history of asthma or recurrent wheezing; (current or within past 2 years); * history of neurological symptoms or signs following administration of any vaccine;
prospective real-world registry describing treatment regimens

Conditions: Subject Under Anticoagulant

Summary: this study is to describe the initial anti-thrombotic treatment strategy prescribed to the af patient population undergoing pci by using drug class description.

coordinator of project has strong expertise in cardiovascular research and especially in acs, pci and antiplatelet therapy. the group led by pr bonello has published several articles (appendix 3) including the vasp studies which have been presented at major cardiologic congresses (late breaking trials acc 2007, aha 2008, tct 2011, europcr 2010) including physicians and biologists. the group is composed of international experts in this research field (pr bonello, pr cuisset, dr barragan, pr lemesle). additionally, coordinator center has a strong expertise in clinical research and a methodological support will be provided by the clinical research platform of the ap-hm (responsible: prof. pascal auquier, medical referent: dr karine baumstarck). the project brings together investigators that have been previously involved in many clinical studies in the field of acs and pci. in particular they have joined forces on multicenter trials leaded by the cardiology department of the hôpital universitaire nord de marseille (the vasp studies, the early clinical trial) and they have regular meetings to share scientific data and research program design and advancement. there is a good capacity and ability of recruitment by the partner centers. the procedures to perform in this project are very simple and the disease is frequent. these are good criteria for the feasibility.

Eligibility criteria:
inclusion criteria: the eligible subjects must meet all of the following criteria: * man or woman 18 years old or over * subject requiring percutaneous coronary intervention according to physician's and with af requiring chronic anticoagulation by dual therapy or triple therapy; * subject with pulmonary embolism risk score \> 1 for men and ≥ 1 for women in cha2ds2-vasc classification * subject having declare its non-opposition to study participation exclusion criteria: * child-bearing potential (1 year post-menopausal, contraceptive or surgically sterile) * lactation * no health insurance * prisoners
association between snp of sp-d and susceptibility and prognosis of infectious keratitis

Conditions: Infectious Keratitis

Summary: this study explores the association between single nucleotide polymorphism (met11thr) of surfactant protein d(sp-d) and susceptibility and prognosis of infectious keratitis.met11thr of sp-d of patients with keratitis and normal controls were compared.allele and genotype frequencies of patients with keratitis and normal controls were determined by polymerase chain reaction with sequence specific primers(pcr-ssps) .sp-d gene polymorphism of patients with keratitis and normal controls was detected by sanger sequencing

surfactant protein d(sp-d) plays an important role in the innate immune system of the eye in the lacrimal duct, cornea and conjunctiva.the single lipopolysaccharide on the surface of bacteria and the receptors on the surface of immune cells are linked by sp-d ,which acts as a bridge to neutralize viruses in the innate immune defense system and assists other immune cells in clearing bacteria and fungi.sp-d can also participate in the acquired immune response after combining with lipopolysaccharide on the surface of microorganisms.some single nucleotide polymorphisms of sp - d can not only affect the plasma level of sp - d, which leads to the differences of pathogen defense capability, but also can affect the space configuration and structure of carbohydrate recognition domain of sp-d, causing the change of ability of sp - d combined with pathogens to influence its defensive role.the concentration of sp - d in ocular surface is closely related to the occurrence and progression of infectious keratitis.association between single nucleotide polymorphisms of sp-d and the occurrence and development of infectious keratitis has yet to be confirmed by research.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of infectious keratitis. * laboratory diagnosis of infectious keratitis. exclusion criteria: * patients with topical or systemic long-term use of hormones, interferon, or immunosuppressive therapy. * patients with basic diseases such as diabetes, autoimmune disease, sjogren's syndrome, blepharitis, eyelid defect or incomplete eyelid closure. * patients with history of corneal myopia laser, cataract surgery and vitrectomy, or history of serious ocular trauma and drug allergies.

Keywords: infectious keratitis surfactant protein d single nucleotide polymorphisms met11thr rs721917
a study to evaluate the safety and effectiveness of pcv chemotherapy in patients with recurrent high-grade glioma with idh1/2 mutation

Conditions: Recurrent High-grade Glioma

Summary: this trial is aimed at evaluating the safety and effectiveness of pcv chemotherapy in patients with recurrent high-grade glioma with idh1/2 mutation.

this trial is aimed at evaluating the safety and effectiveness of pcv chemotherapy in patients with recurrent high-grade glioma with idh1/2 mutation. and, this trial is approved by medical ethics committee of hebei yanda hospital. also, the trial has got a registry code "chictr-ooc-15005759" in china clinical trial registry. researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with idh1/2 mutation patients will be recruited. patients who are recruited will get pcv chemotherapy in ether hebei yanda hospital or beijing tiantan hospital, and get follow-ups from clinicians.

Eligibility criteria:
inclusion criteria: * a diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing. * the report of the pathological diagnosis contained the status of idh gene, and showed that idh1/2 mutation existed. * the age of the patient is between 18 years old and 70 years old. * the condition of the patient permits the procedure of chemotherapy using pcv schema. * the patient is informed consent, and willing to join in this research. exclusion criteria: * the diagnosis is not recurrent high-grade glioma. * the diagnosis of high-grade glioma was not established by pathological method. * no molecular neuropathological report is available, or the report showed that idh1/2 mutation did not exist. * the age of the patient does not meet the requirement of this research. * the condition of the patient does not permit the procedure of chemotherapy using pcv schema. * there are other conditions that the clinicians believe that the pcv chemotherapy is not appropriate for the patient. * the patient is not willing to join in this research.
recurrent extrahepatic bile duct stones as a late complication of ercp in patients with coexisting intra- and extrahepatic bile duct stones

Conditions: Intrahepatic Bile Duct Stone; Choledocholithiasis

Summary: the management of coexisting intrahepatic bile duct (ibd) and extrahepatic bile duct (ebd) stones is complicated and requires a multidisciplinary approach. the long-term clinical outcomes of patients initially treated with endoscopic retrograde cholangiopancreatography (ercp) ebd stone extraction remain unclear. investigators conducted a retrospective study of patients with coexisting ibd and ebd to investigate the long-term impact of ercp on the incidence of recurrent ebd stones and to identify risk factors of recurrence.


Eligibility criteria:
inclusion criteria: * non-gastrointestinal tract reconstruction patients with coexisting ibd and ebd stones who underwent ercp between july 2008 and december 2020 at xijing hospital in china exclusion criteria: * patients with benign or malignant ebd strictures * sclerosing cholangitis * suspected choledochal cysts * liver cirrhosis * parasitic liver diseases * long-term biliary drainage with biliary stents or percutaneous tubes * without a definitive ibd stone or with a diagnosis of liver calcification as determined by imaging review * medical records or follow-up information was unavailable
trial to show non-inferiority / superiority of an endoscopic transforaminal discectomy to standard microdiscectomy

Conditions: Lumbar Disc Herniation

Summary: this study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. clinical parameters as well as health economy will be assessed. the study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.


Eligibility criteria:
inclusion criteria: * symptomatic lumbar disc herniation * clinical and radiological evidence of nerve root compression * failure of conservative treatment for at least 6 weeks exclusion criteria: * previous lumbar spine surgery * severe or progressive motor deficit * bmi \> 40 * cauda equina syndrome

Keywords: lumbar spine herniated disc slipped disc disc herniation discectomy nucleotomy disc surgery endoscopy spine
tinnitus treatment using a smartphone application

Conditions: Tinnitus, Subjective

Summary: people with tinnitus will use a smartpphone app in which they are instructed to reject maladaptive thoughts by throwing them away from themselves (upwards) and embrace supportive thoughts by pulling them towards themselves (downwards). the tinnitus handicap inventory will be used to measure the effect of the application.


Eligibility criteria:
inclusion criteria: * tinnitus lasting more than 3 months exclusion criteria: * brain space occupying lesion
safety and efficacy study of the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines and lateral canthal lines) in subjects with moderate to severe upper facial lines

Conditions: Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)

Summary: the purpose of this study is to investigate the safety and efficacy of nt 201 (active ingredient: botulinum (neuro)toxin type a, free from complexing proteins) in the combined treatment of wrinkles in the upper face (upper facial lines \[ufl\]): horizontal forehead lines \[hfl\], glabellar frown lines \[gfl\], and lateral canthal lines \[lcl\]). it is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (mp) followed by an open-label extension (olex) period.


Eligibility criteria:
inclusion criteria: * outpatients (male or female) 18 years of age or older. * horizontal forehead lines (hfl), glabellar frown lines (gfl), and symmetrical lateral canthal lines (lcl) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to merz aesthetics scales (mas). exclusion criteria: * previous treatment with botulinum neurotoxin (bont) of any serotype in the face within the last 12 months before injection. * any facial cosmetic procedure within the last 12 months before baseline injection. * previous treatment with any biodegradable filler in the face within the last 12 months before injection. * any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study). * any medical condition that may put the subject at increased risk with exposure to nt201.
different sars-cov-2 variants' effect on the course of covid-19 in estonian children

Conditions: COVID - 19; Diabetes Mellitus; Post-COVID Conditions; MIS-C Associated With COVID-19

Summary: the study focuses on estonian children under 18 who had covid-19 from 27.02.2020 to 01.03.2023. the main aim is to find out the risk factors for severe covid-19 in children. in order to do that the study includes their demographic data, vaccination status, and details about the severity of illness, such as hospitalization and long-term effects of covid-19.

data is collected for all children under 18 years old in estonia who were diagnosed with covid-19 between 27.02.2020 and 01.03.2024 (either with the icd-10 codes u07.1/u07.2 and/or a positive sars-cov-2 test. the following data is collected for each patient: age at the time of covid-19 diagnosis, gender, place of residence, and covid-19 vaccination status. in order to assess the severity of the disease, the following data is collected for each case: hospitalization due to covid-19, length of hospitalization, need for intensive care, need for mechanical ventilation, fatal outcomes, and occurrence of long-term sequelae (post-covid-19 condition and pediatric systemic inflammatory response syndrome). additionally, data on any comorbid chronic and acute diseases of the children in the study group is collected. the outcome measures are compared across five different sars-cov-2 voc periods: original, alpha, delta, omicron ba.1/ba.2 and omicron ba.4/ba.5.

Eligibility criteria:
inclusion criteria: * sars-cov-2 positivity or covid-19 diagnosis (icd-10 codes u07.1, u07.2) * covid-19 diagnosis in the following time period: 27/feb/2020 to 01/mar/2023 exclusion criteria: * age above 18 years